START: Swiss Taxotere Alopecia Prevention Trial

January 20, 2012 updated by: Sanofi

A Comparison of Different Scalp Cooling Systems for the Prevention of Chemotherapy Induced Alopecia

Primary objective:

  • Rate of complete chemotherapy induced alopecia (WHO grade III or IV, physician grading)

Secondary objective:

  • Compliance to scalp cooling procedure
  • Received number of cycles of chemotherapy in each subgroup
  • Patient perception of scalp cooling procedure
  • Side effects of scalp cooling systems

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

239

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Any solid tumor malignancy receiving docetaxel (Taxotere®) 1st line chemotherapy treatment with the exception of regimen containing concomitant anthracycline treatment; sequential anthracycline/docetaxel treatment is permitted.
  • Performance Status ECOG <= 2
  • Absence of alopecia at inclusion

Exclusion Criteria:

  • Chemotherapy regimen including concomitant anthracycline treatment
  • Raynaud's disease or phenomenon
  • Cold agglutinin disease
  • Cryoglobulinemia
  • Cryofibrinogenemia
  • Scalp metastasis
  • Pregnancy or Lactation
  • Preexisting alopecia of any grade; notably androgenetic alopecia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A
Device: Paxman Cooling Machine
Scalp cooling procedures
ACTIVE_COMPARATOR: B
Device: Cold Caps
Scalp cooling procedures
NO_INTERVENTION: C

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Grade III or IV alopecia according to the WHO criteria
Time Frame: D1 of each cycle and D+21 after last cycle of chemotherapy
D1 of each cycle and D+21 after last cycle of chemotherapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Compliance to scalp cooling procedure
Time Frame: D1 of each cycle and D+21 after last cycle of chemotherapy
D1 of each cycle and D+21 after last cycle of chemotherapy
Side effects of scalp cooling systems
Time Frame: D1 of each cycle and D+21 after last cycle of chemotherapy
D1 of each cycle and D+21 after last cycle of chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (ACTUAL)

October 1, 2011

Study Completion (ACTUAL)

October 1, 2011

Study Registration Dates

First Submitted

October 1, 2009

First Submitted That Met QC Criteria

November 5, 2009

First Posted (ESTIMATE)

November 6, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 23, 2012

Last Update Submitted That Met QC Criteria

January 20, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DOCET_L_04449

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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